Clinical Trial Manager

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

📋 Description

• Support the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (ie, database hard-lock, final TLFs, CSR, etc.) • Manage the implementation, on-time execution and conduct of clinical studies; including the development of budget items, milestones and timelines, in addition to scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program. • Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines • Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished. • Lead role in vendor identification/qualification/selection, systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.) • Understanding of how to support and deliver the trial endgame, which is the data and statistical analyses • Critically assess data to detect trends and outliers to efficiently direct resources and attention to correct problems early • Ability to critically review and supervise a multifunctional vendor groups including clinical operations, data management and biometrics • Ensure data integrity through routine data reviews, query and resolution, consistency checks both internally and for independent DMC/DSC • Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers • Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary • Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.

🎯 Requirements

• Bachelor’s degree with 5+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience and at least 1 year as CTM • Demonstrated experience in core and technical aspects of designing, initiating and managing phase 1-4 clinical trials • Demonstrated experience in management of CROs, in vendor selection • Possessing excellent interpersonal and communication skills, with demonstrated leadership attributes • Positioned as a subject matter expert in application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards) • Broad scope experience in data collection, monitoring, cleaning and analysis throughout clinical development (Phase 1-4).

🏖️ Benefits

• Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.